UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052235 |
|---|---|
| Receipt number | R000059623 |
| Scientific Title | Prospective Single-Center Randomized Study Comparing Collagen-Based Local Hemostatic Agent with Figure-of-Eight Suture Hemostasis in Femoral Vein Hemorrhage Control. |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/09/18 20:58:17 |
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Basic information
Public title
A Comparative Study of a Novel Venous Hemostasis Device Utilizing Collagen Patches and the Figure-of-Eight Suture Hemostasis.
Acronym
A Comparative Study of a Novel Venous Hemostasis Device and the Figure-of-Eight Suture Hemostasis.
Scientific Title
Prospective Single-Center Randomized Study Comparing Collagen-Based Local Hemostatic Agent with Figure-of-Eight Suture Hemostasis in Femoral Vein Hemorrhage Control.
Scientific Title:Acronym
Prospective Single-Center Randomized Study Comparing Collagen-Based Local Hemostatic Agent with Figure-of-Eight Suture Hemostasis.
Region
| Japan |
Condition
Condition
Arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety differences between conventional figure-of-eight suture hemostasis and a new venous hemostasis device in catheter ablation therapy through a single-center prospective randomized study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to ambulation (time from sheath removal to the initiation of walking without rebleeding).
Time to hemostasis (time from sheath removal until hemostasis is achieved even with manual pressure discontinued).
Procedural success rate (successful achievement of ambulation at the scheduled time per patient without complications).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A new venous disclosure system.
Interventions/Control_2
Figure eight suture hemostasis.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone cardiac catheter ablation using sheaths with an inner diameter ranging from 6-12 French (maximum outer diameter of 15 French), and who are 20 years of age or older and capable of providing informed consent in writing.
Key exclusion criteria
History of previous use of femoral vein hemostasis device (leaving permanent sutures or metal clips).
History of allergy to bovine-derived components.
History of femoral vein stent placement.
If physicians deem the case inappropriate.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5231
sasano.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Goto |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Cardiovascular Medicine, Advanced Arrhythmia Research.
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5231
Homepage URL
kentaro-goto.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Tokyo Medical and Dental University Hospital.
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
